Following Patients through Treatment
Once a patient has begun insulin, it's important to follow the patient’s progress
through treatment. By closely monitoring blood glucose levels, treatment can be
adjusted according to the patient's needs.
Keeping Track of Diet and Exercise
Make sure the patient is making the right lifestyle adjustments, and has learned
how diet and exercise affects the body's blood glucose levels. A Certified Diabetes
Educator or a dietician can work with the patient to create a customized lifestyle
plan.
LANTUS® + OADs vs NPH + OADs in Patients with Type 2 Diabetes32,35
- Study designed to compare efficacy and safety of LANTUS® and NPH32
In a 52-week study, 570 patients with type 2 diabetes poorly controlled by OADs
were randomized to either LANTUS® (n=289) or NPH (n=281) at bedtime to reach a target
FBG of <120 mg/dL. OADs were continued. NPH dose at week 52: 24 Units.
From LANTUS® Prescribing Information,3 data on file,32 and Yki-Järvinen.35
- 0.5% mean A1C reduction at 52 weeks32,35
a Severe symptomatic hypoglycemia was defined
as an event with symptoms consistent with hypoglycemia in which the subjects required
the assistance of another person and which was associated with a BG level <50 mg/dL
or prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration.
From data on file.32
- Hypoglycemic episodes reported as serious AEs: 2 in each treatment group
- Most common AEs possibly related to treatment: "injection site reactions" and "metabolic
and nutritional disorders"
In the Treat-to-Target study
An Appropriate Dose and Proper Titration Helped Many Patients Achieve Glycemic Targets32,33
b Week 0 based on a starting dose of 10 Units.
Average dose at 4 weeks was 25 Units.
From data on file.32
- For the 24-hour glucose-lowering effect of LANTUS®, titrate to FPG33
Data from a 24-week, multicenter, randomized, parallel, open-label trial of 756
overweight men and women compared the abilities and associated hypoglycemic effects
of LANTUS® added to prestudy OADs (n=367) vs NPH added to prestudy OADs (n=389)
in insulin-naive patients with type 2 diabetes and inadequate glycemic control (A1C
>7.5%) on 1 or 2 oral agents (sulfonylureas, metformin, or TZDs) and treated to
a target A1C ≤7.0%. LANTUS® or NPH was administered once daily at bedtime. NPH dose
at study end: 42 Units.
From data on file32
and Riddle.33
- The majority of patients achieved A1C goals
- 1.7% mean A1C reduction at 24 weeks
Effect on Weight (P=NS)
- Weight increased similarly from baseline to endpoint in both arms: 3.0 (±0.2) kg
with LANTUS® and 2.8 (±0.2) kg with NPH
- The dose of LANTUS® should be based on clinical response and individualized according
to the needs of the patient. A reduction in the LANTUS® dose may be required in
patients with renal or hepatic impairment
- In clinical studies in adult patients there was a higher incidence of treatment-emergent
injection-site pain (2.7% LANTUS® vs. 0.7% NPH). The reports of pain at the injection
site were usually mild and did not result in discontinuation of therapy
Helping patients self-monitor
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CONTRAINDICATIONS
Lantus® is contraindicated in patients hypersensitive to insulin glargine or
one of its excipients.
WARNINGS AND PRECAUTIONS
Monitor blood glucose in all patients treated with insulin. Insulin regimens should
be modified cautiously and only under medical supervision. Changes in insulin strength,
manufacturer, type, or method of administration may result in the need for a change
in insulin dose or an adjustment in concomitant oral antidiabetic treatment.
Do not dilute or mix Lantus® with any other insulin or solution. If mixed or
diluted, the solution may become cloudy, and the onset of action/time to peak effect
may be altered in an unpredictable manner. Do not administer Lantus® via an
insulin pump or intravenously because severe hypoglycemia can occur. Insulin devices
and needles must not be shared between patients.
Hypoglycemia is the most common adverse reaction of insulin therapy, including Lantus®,
and may be life-threatening.
Severe life-threatening, generalized allergy, including anaphylaxis, can occur.
A reduction in the Lantus® dose may be required in patients with renal or hepatic
impairment.
DRUG INTERACTIONS
Certain drugs may affect glucose metabolism, requiring insulin dose adjustment and
close monitoring of blood glucose. The signs of hypoglycemia may be reduced in patients
taking anti-adrenergic drugs (e.g., beta-blockers, clonidine, guanethidine, and
reserpine).
ADVERSE REACTIONS
Other adverse reactions commonly associated with Lantus® are injection site
reaction, lipodystrophy, pruritus, and rash.
In clinical studies in adult patients there was a higher incidence of treatment-emergent
injection-site pain (2.7% Lantus® vs. 0.7% NPH). The reports of pain at the injection
site were usually mild and did not result in discontinuation of therapy.
Lantus® SoloSTAR® is a disposable prefilled insulin pen. To help ensure
an accurate dose each time, patients should follow all steps in the Instruction
Leaflet accompanying the pen; otherwise they may not get the correct amount of insulin,
which may affect their blood glucose.
Lantus® is a long-acting insulin analog indicated to improve glycemic control
in adults and children (6 years and older) with type 1 diabetes mellitus and in
adults with type 2 diabetes mellitus. Lantus® should be administered once a
day at the same time every day.
Important Limitations of Use: Lantus® is not recommended for the treatment of
diabetic ketoacidosis. Use intravenous short-acting insulin instead.
Lantus® SoloSTAR® is a disposable prefilled insulin pen.
Please click here for full prescribing information.
CONTRAINDICATIONS
Apidra® is contraindicated during episodes of hypoglycemia and in patients hypersensitive
to Apidra® or any of its excipients.
WARNINGS AND PRECAUTIONS
Closely monitor blood glucose in all patients treated with insulin. Change insulin
regimens cautiously and only under medical supervision. Changes in insulin strength,
manufacturer, type, or method of administration may result in the need for a change
in insulin dose or an adjustment in concomitant oral antidiabetic treatment. As
with all insulin preparations, the time course of Apidra® action may vary by
individual or at different times in the same individual and is dependent on many
conditions, including the site of injection, local blood supply, or local temperature.
Hypoglycemia is the most common adverse reaction of insulin therapy, including Apidra®,
which may be serious.
Severe life-threatening, generalized allergy, including anaphylaxis, can occur.
All insulins, including Apidra®, can cause hypokalemia, which if untreated,
may be serious.
A reduction in the Apidra® dose may be required in patients with renal or hepatic
impairment.
Apidra® for subcutaneous injection should not be mixed with insulins other than
NPH. Do not mix Apidra® with any insulin when used in the pump or for intravenous
administration. Insulin devices and needles must not be shared between patients.
DRUG INTERACTIONS
Certain drugs may affect glucose metabolism, requiring insulin dose adjustment and
close monitoring of blood glucose. The signs of hypoglycemia may be reduced in patients
taking anti-adrenergic drugs (e.g., beta-blockers, clonidine, guanethidine, and
reserpine).
ADVERSE REACTIONS
Other adverse reactions commonly associated with Apidra® include injection site
reactions, lipodystrophy, pruritus, and rash.
Apidra® is a rapid-acting insulin analog indicated to improve glycemic control
in adults with type 2 diabetes or adults and children (4 years and older) with type
1 diabetes.
When used as a mealtime insulin, the dose of Apidra® should be given within 15 minutes
before or within 20 minutes after starting a meal. Apidra® given by subcutaneous injection
should normally be used in regimens that include a longer-acting insulin.
Please click here for full prescribing information for Apidra®
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